Improving Sleep for Healthy Hearts

NCT ID: NCT02848859

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-12-31

Brief Summary

This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).

Detailed Description

For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.

Conditions

Insomnia; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Go! to Sleep

We are using a web-based cognitive behavioral therapy program called Go! to Sleep. Go! to Sleep is an interactive online program developed by specialists in Cleveland Clinic's Wellness Institute and Sleep Disorders Center. The program is a 6 week self-help program that uses cognitive behavioral therapy techniques that have been proven to be effective in decreasing symptoms of insomnia.

Group Type: ACTIVE_COMPARATOR

Go! to Sleep

Intervention Type: BEHAVIORAL

This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.

General Sleep Education

Intervention Type: BEHAVIORAL

Providing patients information on healthy sleep and habits to promote healthy sleep.

General Sleep Hygiene Education

General Sleep Hygiene Education is the first step in the treatment of any sleep disorder. Both arms will have access to a Harvard sleep education web site that provides general information about sleep as well as sleep hygiene.

Group Type: PLACEBO_COMPARATOR

General Sleep Education

Intervention Type: BEHAVIORAL

Providing patients information on healthy sleep and habits to promote healthy sleep.

Interventions

Go! to Sleep

This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.

Intervention Type: BEHAVIORAL

General Sleep Education

Providing patients information on healthy sleep and habits to promote healthy sleep.

Intervention Type: BEHAVIORAL

Other Intervention Names

web-based cognitive behavioral therapy

Eligibility Criteria

Inclusion Criteria

• meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
• have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
• minimum age of 18 years old.

Exclusion Criteria

• no daily access to a computer with an internet connection
• visual impairment preventing use of a computer
• inability to read English
• severe uncontrolled medical or psychiatric problems
• heart failure with reduced ejection fraction <35%
• high depressive symptoms (PHQ > 15)
• drowsy driving
• >3 days per week use of hypnotic medications
• known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome
• shift-workers
• prior exposure to CBT-I treatment
• dialysis patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Susan Redline

Senior Physician, Division of Sleep and Circadian Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Redline, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Sogol Javaheri, MD, MA

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

Brigham and Womens Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2014P000845

Identifier Type: -

Identifier Source: org_study_id